A Study of the Efficacy and Safety of SP-624 in the Treatment of Adults With Major Depressive Disorder
NCT ID: NCT06254612
Last Updated: 2025-11-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2
456 participants
INTERVENTIONAL
2024-03-25
2026-07-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study to Explore the Effect of SP-624 on Brain Network Analytics in Healthy Adults and Adults With Major Depression
NCT06570369
Double-blind, Placebo-controlled Study in Adults With Major Depressive Disorder
NCT07226661
Investigate Efficacy & Safety of RO4995819 vs. Placebo as Adjunct Tx in Patients w/Major Depressive Disorder
NCT01733654
A Study to Evaluate the Efficacy of SAGE-217 in the Treatment of Adult Participants With Major Depressive Disorder
NCT03672175
Study of BMS-562086 in the Treatment of Outpatients With Major Depressive Disorder
NCT00135421
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
SP-624
Participants to receive two 10 mg capsules of SP-624 once daily for a total daily dose of 20 mg
SP-624
Once daily oral administration of two capsules totaling 20 mg/day
Placebo
Participant to receive 2 matching placebo capsules once daily
Placebo
Once daily oral administration of two matching placebo capsules
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
SP-624
Once daily oral administration of two capsules totaling 20 mg/day
Placebo
Once daily oral administration of two matching placebo capsules
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Meet DSM-5 criteria for moderate to severe MDD, as confirmed by the Mini International Neuropsychiatric Interview (MINI).
* In generally good physical health, in the opinion of the Investigator.
* Body mass index (BMI) must be ≥ 18 and ≤ 45 kg/m2.
Exclusion Criteria
* A history of or current DSM-5 diagnosis of MDD with psychotic features, any schizophrenia spectrum and other psychotic disorders, bipolar disorder, or personality disorder.
* Presence or history of any known clinically significant cardiovascular disorders including, but not limited to: coronary artery disease, heart failure, valvular heart disease, cardiomyopathies, myocardial infarction, chamber enlargement or hypertrophy, or orthostatic hypotension.
* Presence of uncontrolled hypertension, defined as consistent sitting systolic blood pressure (SBP) \>160 mmHg or consistent sitting diastolic blood pressure (DBP) \>95 mmHg despite present therapy.
* Screening laboratory value(s) outside the laboratory reference range that are considered to be clinically significant by the Investigator (clinical chemistry, hematology, thyroid function, and urinalysis).
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Rho, Inc.
INDUSTRY
Sirtsei Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Greg Rigdon, PhD
Role: STUDY_DIRECTOR
Sirtsei Pharmaceuticals, Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
IMA Clinical Research
Phoenix, Arizona, United States
Noble Clinical Research
Tucson, Arizona, United States
SanRo Clinical Research Group
Bryant, Arkansas, United States
Clinical Innovations
Bellflower, California, United States
Sun Valley Research Center
Imperial, California, United States
Sunwise Clinical Research
Lafayette, California, United States
Synergy San Diego
Lemon Grove, California, United States
Excell Research
Oceanside, California, United States
CiTrials
Riverside, California, United States
Collaborative Neuroscience Research
Torrance, California, United States
Next Level Clinical Trials
West Covina, California, United States
MCB Clinical Research Centers
Colorado Springs, Colorado, United States
Clinical Neuroscience Solutions
Jacksonville, Florida, United States
Accel Clinical
Lakeland, Florida, United States
Segal Trials
Lauderhill, Florida, United States
Segal Trials - Miami Lakes
Miami Lakes, Florida, United States
Clinical Neuroscience Solutions
Orlando, Florida, United States
DMI Research
Pinellas Park, Florida, United States
Accelerated Enrollment Solutions
Atlanta, Georgia, United States
Velocity Clinical Research
Meridian, Idaho, United States
Revive Research Institute
Elgin, Illinois, United States
Tandem Clinical Research
Marrero, Louisiana, United States
Boston Clinical Trials
Boston, Massachusetts, United States
Neurobehavioral Medicine Group
Bloomfield Hills, Michigan, United States
Midwest Research Group
Saint Charles, Missouri, United States
Alivation Research
Lincoln, Nebraska, United States
IMA Clinical Research
Las Vegas, Nevada, United States
Redbird Research
Las Vegas, Nevada, United States
Center for Emotional Fitness
Cherry Hill, New Jersey, United States
CenExel HRI
Marlton, New Jersey, United States
IMA Clinical Research
Albuquerque, New Mexico, United States
Integrative Clinical Trials
Brooklyn, New York, United States
Pioneer Clinical Research
New York, New York, United States
Magnolia Clinical Research
Cary, North Carolina, United States
UNC Chapel Hill
Chapel Hill, North Carolina, United States
New Hope Clinical Research
Charlotte, North Carolina, United States
Velocity Clinical Research
Beachwood, Ohio, United States
Midwest Clinical Research Center
Dayton, Ohio, United States
North Star Medical Research
Middleburg Heights, Ohio, United States
Summit Headlands
Portland, Oregon, United States
Coastal Carolina Research Center
North Charleston, South Carolina, United States
Clinical Neuroscience Solutions
Memphis, Tennessee, United States
Donald J. Garcia, Jr, MD, PA
Austin, Texas, United States
Future Search Trials of Dallas
Dallas, Texas, United States
Haracec Clinical Research
El Paso, Texas, United States
Pillar Clinical Research
Richardson, Texas, United States
R and H Clinical Research
Stafford, Texas, United States
Grayline Research Center
Wichita Falls, Texas, United States
Northwest Clinical Research Center
Bellevue, Washington, United States
Core Clinical Research
Everett, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Recruitment Director
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Recruitment Coordinator
Role: primary
Study Coordinator
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
Raskin J, Clayton AH, Kornstein SG, Papakostas GI, Prescott Y, Abernathy K, Hall J, Ackermann M, Wargin W, Rigdon G, Arnold V, Ball R, Cohen E, Garcia DJ Jr, DiBuono M, Downing M, Dueno O, Essink B, Gamez C, Goenjian H, Greenbaum M, Gross P, Holloway W, Joyce JM, Konis G, Kunovac J, Lerman M, Acevedo-Diaz E, Rawaf M, Rosenberg L, Shirikjian L, Kakar R, Suplicy F, Tran D, Vatakis N, Joseph J, Knutson J, Abraham K, Ginsberg L, Mattingly G, Chavez E, Maass-Robinson S, Sedillo A, Barnhart B. A Phase 2, multicenter, double-blind, randomized, placebo-controlled study of the safety and efficacy of forvisirvat (SP-624) in the treatment of adults with major depressive disorder. Curr Med Res Opin. 2025 Oct 16:1-16. doi: 10.1080/03007995.2025.2574465. Online ahead of print.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SP-624-202
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.